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حالة تأهب وظيفة
سيتم تحديثك بأحدث تنبيهات الوظائف عبر البريد الإلكترونيحالة تأهب وظيفة
سيتم تحديثك بأحدث تنبيهات الوظائف عبر البريد الإلكترونيAbout the job
The Site Activation Partner is responsible for leading or supporting operational activities from startup to closeout for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws Good Clinical Practices and Pfizer standards. Responsibility within a country and may span over more than one country depending on the geographical region and business needs.
Role Responsibilities
Clinical Trial Site Activation
Initiate and coordinate activities and essential documents management during startup towards the compilation of a highquality Investigator Initiation Package (IIP) leading to approval for site initiation
Provide support to resolve issues or concerns and timely escalation of Site issues where applicable
Prepare validate and submit regulatory documents such as completed IIP IRB approval forms FDA 1572/Attestation Form for internal regulatory approval within required timelines
Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.
Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements
Coordinate the timely communication documentation and responses between Pfizer and Central Ethics committee to bring clinical study to approval (country dependent)
Support investigators sites with local IRB workflow from preparation submission through approval
Assist with the preparation handling and distribution of clinical documentation and reports according to the scope of work and standard operating procedures.
Support implement activities in Shared Investigator Platform to align with Pfizer strategy as it relates to the role
Clinical Trials Conduct
Post site activation initiate and coordinate activities and essential documents management with the investigators sites towards the compilation of a highquality documents and updates through the life cycle of a study such as the documents management for protocol amendments FDA 1572/Attestation revisions Ethics Committee annual approvals and other activities required during study conduct
Ensure maintenance of IRB/Ethics and other committees activities as applicable
Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness
Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
Supports investigator sites and study teams in preparation for and providing responses to site audits / inspections
Internal External Communication
Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests
Provide functional updates on a country and site level as required
Establish tools for efficient updates to study team as needed regarding site status issues delays approvals
Disseminate Central or Local Ethics Approval to study team and Investigator Sites where applicable
Communicate Local sites approvals to study team members and stakeholders
Clinical Trial Site Support
As needed perform awareness session with site personnel on Pfizer requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws Good Clinical Practices and Pfizer standards
Identify and resolve investigator site issues within required timeframes; align with study team and local country colleagues on corrective and preventative actions to close open issues and to prevent recurrence / persistence of issues
Additional Responsibilities:
A good understanding of the Site Activation requirements and processes within the country/region and be able to learn and potentially implement in more than one (1) country
May be assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multicountry
May be assigned as an SME on a system and/or process and represent the SAP function as applicable
May represent the SAP role on global initiatives
Able to act as an SME on projects and initiatives as requested
Support the mentoring of new hires on processes/ systems
Systems Tools
Ability to use and learn systems and to use independently
Microsoft Suite
Clinical Trial Management Systems (CTMS)
Electronic Trial Master File
Electronic Investigator Site File (e.g. Florence)
Document exchange portals
Shared Investigator Platform
Ethics National Networks and Governing Bodies Portals and platforms (as needed)
Qualifications / Skills
BASIC QUALIFICATIONS
BS/BA or bachelors degree in Life Sciences preferred
26 years relevant experience in Clinical Site Management.
Experience working in the pharmaceutical industry/or CRO in study site activation is an asset
Knowledge of clinical trial methodologies ICH/GCP FDA and Global and local country regulations
Must be fluent in Local language and in English. Multilanguage capability is an asset
For individuals based in Canada: Bilingualism (French English) is an asset
Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
Good technical skills and ability to learn and use multiple systems
Physical/Mental Requirements
Demonstrated knowledge of clinical research and development processes Key operational elements of a clinical trial and ability to gain command of process details
Understand the quality expectations and emphasis on right first time. Demonstrate compliance with all applicable company regulatory and country requirements. Attention to detail evident in a disciplined approach
Ability to work independently and also as a team member
Ability to organize tasks time and priorities ability to multitask
Understand basic medical terminology GCP requirements and proficient in computer operations
ORGANIZATIONAL RELATIONSHIPS
Global Study Manager and StartUp Project Manager Global Study Clinician
Local Site Relationship Partners and Director Clinical Site Operations Clinical Trials Manager and other Local Roles
Global Investigator Initiation Package (IIP) Regulatory Group
Local Regulatory Manager CTA Hub and CTA Submission Managers
Site Intelligence Team
Contract specialists
Investigators Sites
Country Ethics Committee representatives
Other governing bodies representatives
Local provincial/States and national networks
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Remote Work :
No
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